Steps of Certification
Step 1: Request Application
The first step in the process is to obtain an Application Package from
the AOAC-RI. This package contains information about the program, what
types of data are required, application fees, and the agreements (downloadable forms). Our Coordinator will help guide you through what is needed along with the advantages of speaking further with one of our outstanding Consultants. Please call: +301-924-7077 x129.
Step 2: Submit Performance Data
Manufacturers are required to collect and submit data to the AOAC-RI
that supports the product performance claims of the test kit. This data
should follow the guideline of the Data Submission Requirement documents
and be submitted in a method validation report format. In addition, the
manufacturer must submit QA/QC information, package insert/user manuals,
fee, and application.
Step 3: Review of Submitted Data
Usually two Expert Reviewers are recruited and one General Referee
(selected by the AOAC-RI) review the performance data collected and submitted
by the mehtod manufacturer. The Expert Reviewers and the General Referee
first evaluate the product descriptive inserts to determine the completeness
of the inserts and to determine the exact performance claims made for the
method. Tthe Expert Reviewers and the General Referee will then evaluate the
submitted performance data to determine whether or not the data supports
the product.
Step 4: Development of Independent Testing Lab
Protocols
After the Expert Reviewers and General Referee have determined the
adequacy of the product descriptive inserts, and confirmed that the submitted
data supports the product performance claims, the Expert Reviewers
and General Referee develop a testing protocol for the Independent Testing
Laboratory (selected by the AOAC-RI) to conduct additional performance testing
of the method.
Step 5: Independent Testing
Methods, samples and the testing protocol developed by the Expert
Reviewers and the General Referee are forwarded to the Independent Testing
Laboratory, who then conducts additional performance testing of the method.
Step 6: Review of Independent Testing Lab Data
The data generated by the Independent Testing Lab is sent to the AOAC-RI, and then distributed back to the Expert Reviewers and the General Referee.
The Expert Reviewers and the General Referee then review the data generated
by the Independent Testing Lab to determine whether or not this data corroborates
with the data originally submitted by the manufacturer.
Step 7: Recommendation
If the Expert Reviewers and the General Referee determine that the
Independent Testing Lab data corroborates with the manufacturer's
submitted data and the product descriptive inserts
adequately describe the product performance, then a recommendation is made
to grant Performance Tested Methodssm status to the test kit, and the kit
manufacturer is licensed to use the certification mark for one year.
APPROVAL
Publication
Successful method certifications will be announced in the AOAC magazine,
Inside
Laboratory Management (ILM), with selected portions of the performance data
of the test kit published. A more complete method validation
report describing the method and the evaluation is published in the Journal of the AOAC INTERNATIONAL.
Annual Renewal
Performance Tested Methodssm status must be renewed on an annual
basis. AOAC-RI reviews the method's package insert and user manual to ensure that the
kit still conforms to the previously granted Performance Tested Methodssm
certification. The manufacturer must inform the AOAC-RI immediatley if changes have been made to the method, package insert,
manufacturing and/or quality assurance programs since originally receiving
Performance
Tested Methodssm status. This annual review ensures that no changes have
occurred in the method that may adversely affect the performance of the
method and ensures that the package inserts and user manual remain accurate, thus providing the end-user with the confidence of maintaning consistency in the method.
Changes in the Test Kit
It is the method manufacturer's contractual obligation to immediately
notify the AOAC-RI if and when any changes are made to: (1) the instructions
for using the kit or (2) the kit's performance. Failure to promptly
notify the AOAC-RI of kit changes may result in cancellation of the Performance
Tested Methodssm certificate. If changes are made in the method,
the submission of new performance data similar to the original data package
must be provided. When the AOAC-RI receives notice of a method change, the
managing director, generally in consultation with appropriate experts,
will determine if the changes are of sufficient magnitude to warrant a
complete re-evaluation of the method. If so, the applicant of record must submit
a complete application with the corresponding fee.
Complaints
The manufacturer must maintain a record of complaints and their resolution,
which will be made available to the AOAC-RI on request. Failure to adequately
address user complaints will result in the AOAC-RI initiating an inquiry
and could lead to cancellation of themethod's Performance Tested Methodssm
status.
